Dacogen

Dacogen Special Precautions

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
Myelosuppression: Myelosuppression and complications of myelosuppression, including infections and bleeding that occur in patients with MDS or AML may be exacerbated with DACOGEN treatment. Myelosuppression caused by DACOGEN is reversible. Complete blood and platelet counts should be performed regularly, as clinically indicated and prior to each treatment cycle. In the presence of myelosuppression or its complications, treatment with DACOGEN may be interrupted, the dose reduced or supportive measures instituted as recommended in Dosage & Administration, Adverse Reactions.
Hepatic Impairment: The use of DACOGEN in patients with hepatic impairment has not been established. Caution should be exercised in the administration of DACOGEN to patients with hepatic impairment or in patients who develop signs or symptoms of hepatic impairment. Patients should be monitored closely (see Dosage and Administration, Pharmacology: Pharmacokinetics under Actions).
Renal Impairment: The use of DACOGEN in patients with severe renal impairment has not been studied. Caution should be exercised in the administration of DACOGEN to patients with severe renal impairment (Creatinine Clearance [CrCl] <30 mL/min) and these patients should be monitored closely (see Dosage & Administration).
Cardiac Disease: Patients with a history of severe congestive heart failure or clinically unstable cardiac disease were excluded from clinical studies and therefore the safety and efficacy of DACOGEN in these patients has not been established.
Effects on Ability to Drive and Use Machines: No studies of the effects on the ability to drive or use machines with DACOGEN have been performed. Patients should be advised that they may experience undesirable effects, such as anemia, during treatment. Therefore, caution should be recommended when driving a car or operating machines.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in